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| Product NDC Code | 71229-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Funginix anti-fungal treatment |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| Application Number | M005 | ||||
| Labeler Name | The Sisquoc Healthcare Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT UNDECYLENIC ACID 10%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS For the cure of most ringworm (tinea corporis) and athlete’s foot (tinea pedis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions. Clean the affected area with soap and warm water and dry thoroughly. Apply a thin layer of FUNGINIX over the affected area twice daily (morning and night), or as directed by a physician. Allow 3-5 minutes for the solution to penetrate the skin and absorb fully into the surrounding tissue. FUNGINIX should be applied to cuticles, around nail edges and under nail tips where reachable with the applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces. For athlete’s foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Oleth-10 Phosphate, Triethanolamine, Polysorbate 20, Acrylates Copolymer, Glycerin, Propylene Glycol, Uva Ursi (Bearberry) Extract, Beta-Glucan, Propolis Extract, Aloe Barbadensis Juice, Tocopheryl Acetate (Vitamin E), Camphor, Menthol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Jasminum Offi cinale (Jasmine Oil, Eugenia Caryophyllus (Clove) Flower Oil, Theobroma Cacao (Cocoa) Seed Butter, Rosa Canina (Rose Hip) Flower Oil, Cetyl Hydroxyethylcellulose, Ethylhexylglycerin, Phenoxyethanol
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USES ANTI-FUNGAL TREATMENT
Purpose
Information about the drug product’s indications for use.PURPOSE ANTIFUNGAL
Spl product data elements
Usually a list of ingredients in a drug product.FUNGINIX ANTI-FUNGAL TREATMENT UNDECYLENIC ACID WATER ALMOND OIL OLETH-10 PHOSPHATE TROLAMINE POLYSORBATE 20 BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) GLYCERIN PROPYLENE GLYCOL ARCTOSTAPHYLOS UVA-URSI WHOLE OAT PROPOLIS WAX ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE CAMPHOR OIL MENTHOL TEA TREE OIL LAVENDER OIL JASMINUM OFFICINALE WHOLE CLOVE OIL COCOA BUTTER ROSA CANINA FLOWER OIL CETYL HYDROXYETHYLCELLULOSE (350000 MW) PHENOXYETHANOL ETHYLHEXYLGLYCERIN UNDECYLENIC ACID UNDECYLENIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Funginix Label Funginix Insert
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Storage and handling
Information about safe storage and handling of the drug product.Store between 20°c to 25°C (68° to 77°F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS FOR EXTERNAL USE ONLY. DO NOT USE ON CHILDREN UNDER 2 YEARS OF AGE UNLESS DIRECTED BY A DOCTOR. WHEN USING THIS PRODUCT AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE THE EYES VERY THOROUGHLY WITH WATER. STOP USE AND ASK A DOCTOR IF IRRITATION OCCURS OR THERE IS NO IMPROVEMENT WITHIN 4 WEEKS.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API